| ID | Type | Description | Link |
|---|---|---|---|
| TMC114-TiDP31-C229 | Other Identifier | Tibotec Pharmaceuticals, Ireland | |
| 2007-001939-61 | EudraCT Number |
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The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRV/rtv 800/100 mg once daily | Experimental | Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily. |
|
| DRV/rtv 600/100 mg twice daily | Experimental | One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir (DRV) | Drug | DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48. | 48 weeks |
| Change in log10 Viral Load From Baseline at Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec Pharmaceuticals, Ireland Clinical Trial | Tibotec Pharmaceuticals, Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23558157 | Derived | Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4. |
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In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.
One hundred thirteen investigators in 21 countries participated in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | DRV/Rtv 800/100 mg Once Daily | Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily |
| FG001 | DRV/Rtv 600/100 mg Twice Daily | One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ritonavir (rtv) | Drug | DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily. |
|
|
| 48 weeks |
| Time to Reach First Virologic Response | Time (in weeks) to achieve viral load less than 50 copies/mL by the participants. | 48 weeks |
| Time to Loss of Virologic Response | Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants. | 48 weeks |
| Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | 48 weeks |
| Change in CD4+ Cell Count From Baseline | CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm. | 48 Weeks |
| Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening. | 48 weeks |
| Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days. | 48 weeks |
| Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. |
| Predose Plasma Concentration (C0h) of DRV and Rtv. | Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48 |
| Number of Participants Developing Mutations at Endpoint | Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint. | 48 weeks |
| Little Rock |
| Arkansas |
| United States |
| Beverly Hills | California | United States |
| Oakland | California | United States |
| Palm Springs | California | United States |
| Fort Lauderdale | Florida | United States |
| Fort Laudersale | Florida | United States |
| Miami | Florida | United States |
| Miami Beach | Florida | United States |
| Orlando | Florida | United States |
| Safety Harbor | Florida | United States |
| West Palm Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Macon | Georgia | United States |
| Savannah | Georgia | United States |
| Chicago | Illinois | United States |
| Springfield | Massachusetts | United States |
| Berkley | Michigan | United States |
| Newark | New Jersey | United States |
| Albany | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| The Bronx | New York | United States |
| Huntersville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Harlingen | Texas | United States |
| Houston | Texas | United States |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| Guernica | Argentina |
| Neuquén | Argentina |
| Rosario | Argentina |
| Darlinghurst | Australia |
| Surry Hills | Australia |
| Vienna | Austria |
| Curitiba | Brazil |
| Distrito Barao Geraldo-Campina | Brazil |
| Pinheiros | Brazil |
| Recife | Brazil |
| Rio de Janeiro | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Providencia | Chile |
| Santiago | Chile |
| Lyon | France |
| Nice | France |
| Orléans | France |
| Paris | France |
| Vandœuvre-lès-Nancy | France |
| Berlin | Germany |
| Cologne | Germany |
| München | Germany |
| Guatemala City | Guatemala |
| Budapest | Hungary |
| Ipoh | Malaysia |
| Kuala Lumpur | Malaysia |
| Pulau Pinang | Malaysia |
| Sungai Buloh | Malaysia |
| Panama City | Panama |
| San Juan | Puerto Rico |
| Bucharest | Romania |
| Constanța | Romania |
| Iași | Romania |
| Timișoara | Romania |
| Cape Town | South Africa |
| Cyrildene Johannesburg Gauteng | South Africa |
| Dundee | South Africa |
| Durban | South Africa |
| Houghton, Johannesburg | South Africa |
| Johannesburg | South Africa |
| Pretoria | South Africa |
| Westdene Johannesburg Gauteng | South Africa |
| Barcelona | Spain |
| Madrid | Spain |
| Kaohsiung County | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Khon Kaen | Thailand |
| Nonthaburi | Thailand |
| London | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DRV/Rtv 800/100 mg Once Daily | Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily |
| BG001 | DRV/Rtv 600/100 mg Twice Daily | One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Age (years) (categorical) | Number | participants |
| ||||||||||||||||
| Hepatitis B or C Co-infection Status | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Posted | Number | Participants | 48 Weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48. | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Posted | Number | Participants | 48 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in log10 Viral Load From Baseline at Week 48 | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Posted | Median | Full Range | log10 copies/mL | 48 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach First Virologic Response | Time (in weeks) to achieve viral load less than 50 copies/mL by the participants. | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Posted | Median | Full Range | Days | 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response | Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants. | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Posted | Mean | Standard Error | Days | 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | Intention To Treat (ITT) population: Observed cases | Posted | Least Squares Mean | Standard Error | log10 copies/mL | 48 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4+ Cell Count From Baseline | CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm. | Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation. | Posted | Median | Full Range | 10e6/l | 48 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening. | Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation. | Posted | Median | Full Range | Scores on a scale | 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days. | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Posted | Number | Percentage of participants | 48 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Posted | Median | Full Range | ng*h/mL | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Predose Plasma Concentration (C0h) of DRV and Rtv. | Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Posted | Median | Full Range | ng/mL | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Mutations at Endpoint | Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint. | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Posted | Number | Participants | 48 weeks |
|
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DRV/Rtv 800/100 mg Once Daily | Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily | 16 | 294 | 134 | 294 | ||
| EG001 | DRV/Rtv 600/100 mg Twice Daily | One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily | 27 | 296 | 147 | 296 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis cryptosporidial | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Toxoplasmosis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Extrapulmonary tuberculosis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pulmonary bulla | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Whiplash injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Angiodermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vulval ulceration | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 11.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
The Sponsor will not unreasonably withhold consent to publish the data generated in this trial. However, it is the policy of the Sponsor not to allow the investigators to publish their results or findings prior to the Sponsor's publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Tibotec Pharmaceuticals, Ireland | +32 015 461 497 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
Not provided
Not provided
| Male |
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| 30 < Age <= 45 |
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| 45 < Age <= 55 |
|
| 55 < Age <= 65 |
|
| Age > 65 |
|
| Positive |
|
| Unknown |
|
| Yes |
| Non-Inferiority or Equivalence |
If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded. |
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